NCT06381063 Non-steroidal Anti-inflammatory in Cardiac Surgery
| NCT ID | NCT06381063 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Acute Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 238 participants |
| Start Date | 2024-03-27 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 238 participants in total. It began in 2024-03-27 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication.
Eligibility Criteria
Inclusion Criteria: * scheduled for cardiac surgery (aortic valve replacement, coronary artery bypass graft, mitral valve repair or replacement, intracardiac tumor, aortic root repair) * under cardiopulmonary bypass * Affiliation to the French national healthcare system * Written consent obtained Exclusion Criteria: * age\<18 * weight\<50 kg * chronic use of NSAID * mini-invasive surgery * NSAID contraindication * NSAID allergy * Nefopam contraindication * Paracetamol contraindication * Tramadol contraindication * Urgent surgery * Endocarditis * Immunosuppressive drug * HIV infection with CD4\<200 mm3 * Organ transplantation * Stage 4 or 5 chronic kidney disease * Gastro duodenal ulcer * Pregnancy * Depression * Auto immune disease
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06381063 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06381063 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 238 participants.
Is NCT06381063 currently recruiting?
Yes, NCT06381063 is actively recruiting participants. Contact the research team at abouarab.osama@chu-amiens.fr for enrollment information.
Where is the NCT06381063 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT06381063 clinical trial?
NCT06381063 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 238 participants.